NDC 53675-165

Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection

Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone

Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Aruba Aloe Balm Nv. The primary component is Avobenzone; Homosalate; Octinoxate; Octisalate; Octocrylene; Oxybenzone.

• Product ID: 53675-165_5fc8ccf5-f578-048e-e053-2a91aa0a6263
• NDC: 53675-165
• Product Type: Human Otc Drug
• Proprietary Name: Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection
• Generic Name: Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-06-10
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Aruba Aloe Balm NV
• Substance Name: AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
• Active Ingredient Strength: 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 53675-165-00

59 mL in 1 TUBE (53675-165-00)

• Marketing Start Date: 2017-06-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53675-165-00 [53675016500]

Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-06-10

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	30 mg/mL

OpenFDA Data

• SPL SET ID: 1068ef02-983a-49be-89b2-0ec33fa369e1
• Manufacturer:
  • Aruba Aloe Balm NV
• UNII:
  • 5A68WGF6WM
  • V06SV4M95S
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 4Y5P7MUD51
  • G63QQF2NOX

NDC Crossover Matching brand name "Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection" or generic name "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone"

NDC	Brand Name	Generic Name
53675-165	Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
11523-7430	Coppertone Kids Sport SPF 100	avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone
11523-7427	Coppertone Sport SPF 100	avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone
69842-117	CVS Health	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
51316-020	CVS Health SPF 100 Clear	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-045	FOTE BLOCK UP KIDS SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
62217-004	Fruit of the Earth	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-005	Fruit of the Earth	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-008	Fruit of the Earth	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-013	Fruit of the Earth	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-017	Fruit of the Earth	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-024	Fruit of the Earth	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-050	Fruit of the Earth	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-350	Fruit of the Earth	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
67751-181	Fruit of the Earth	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-174	Fruit of the Earth Block Up	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-186	Fruit of the Earth Block Up	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62217-006	Fruit of the Earth, Inc.	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
30142-932	Kroger Kids SPF 50 Sunstick	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
30142-933	Kroger Sport SPF 50 Sunstick	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
49825-201	SPF 50 Face Sunscreen	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
56152-4008	SPF 50 Face Sunscreen	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62670-8046	True Blue Spa Cooling Sunscreen Mist Broad Spectrum SPF 25 Water Resistant (40 minutes) Monoi Oil	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
59886-350	ULTRASOL	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
59886-351	ULTRASOL	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
59886-352	ULTRASOL	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
59886-340	UltrasolSunscreen	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
59886-346	UltrasolSunscreen	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
59886-347	UltrasolSunscreen	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
59886-348	UltrasolSunscreen	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62670-8049	Victorias Secret Pink Broad Spectrum SPF 25 Sunscreen Sunkissed	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
62670-8048	Victorias Secret Sun Broad Spectrum SPF 25	Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone